Not Cleared Direct

DEN130031 - NEPHROCHECK TEST SYSTEM (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130031 · Astute Medical, Inc. · Chemistry device
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Sep 2014
Decision
457d
Days
Class 2
Risk

DEN130031 is an FDA 510(k) submission (not cleared) for the NEPHROCHECK TEST SYSTEM. Classified as Acute Kidney Injury Test System (product code PIG), Class II - Special Controls.

Submitted by Astute Medical, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on September 5, 2014 after a review of 457 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1220 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 457 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Astute Medical, Inc. devices

Submission Details

510(k) Number DEN130031 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 05, 2013
Decision Date September 05, 2014
Days to Decision 457 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
369d slower than avg
Panel avg: 88d · This submission: 457d
Pathway characteristics

Device Classification

Product Code PIG Acute Kidney Injury Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1220
Definition An Acute Kidney Injury Test System Is Intended To Measure One Or More Analytes In Human Samples As An Aid In The Assessment Of A Patient's Risk For Developing Acute Kidney Injury. Test Results Are Intended To Be Used In Conjunction With Other Clinical And Diagnostic Findings, Consistent With Professional Standards Of Practice, Including Conifmration By Alternative Methods.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.